IV Line Placement With UltrasoundNCT06296264
Ultra-portable Ultrasound vs. Standard Ultrasound to Help Place a Peripheral Catheter in Patients at Risk of Difficult Puncture
A study testing Standard ultrasound and Ultra-portable ultrasound in people with IV Line Placement With Ultrasound, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site in France.
Trial summary
The placement of an intravenous (IV) line is a common procedure when treating adult patients in critical care, in the emergency room or in the operating room. This simple and minimally invasive procedure can sometimes be made difficult depending on the patient's morphology or their clinical condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IV Line Placement With Ultrasound
- What is being tested?
- Standard ultrasound and Ultra-portable ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 27 Aug 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged at least 18 years old
- Patient with an A-DIVA (Adult Difficult Intravenous Access) score > 1
- Supported by a nurse trained in all the techniques used in the protocol
- Patient having given free, informed and oral consent -
Who cannot join
- Patient who has already been included in the study
- Patient whose inclusion in the study would lead to a delay in treatment
- Adult patient protected by law
- Pregnant woman
- Patient not benefiting from French Social Security system -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Saint Joseph Saint Luc Hospital
Lyon, Auvergne-Rhône-Alpes, 69007
Emmanuel VIVIER, MD, 0033478618209, evivier@saintjosephsaintluc.fr
Fanny DOROSZEWSKI, Mrs, 0033478618398, fdoroszewski@saintjosephsaintluc.fr
About this study
The placement of an intravenous (IV) line is a common procedure when treating adult patients in critical care, in the emergency room or in the operating room. This simple and minimally invasive procedure can sometimes be made difficult depending on the patient's morphology or their clinical condition. The procedure then becomes time-consuming, anxiety-provoking, painful and its success is uncertain.
The placement of intravenous (IV) lines under ultrasound by nurses is a rapidly developing alternative in intensive care, emergencies and the operating room.
Read the detailed description
The main objective is to test the hypothesis that intravenous puncture guided by an ultraportable ultrasound machine is faster than puncture guided by a conventional ultrasound machine.
- Conditions
- IV Line Placement With Ultrasound
- Being tested
- Standard ultrasound, Ultra-portable ultrasound
- Keywords
- IV line, Ultra-portable ultrasound, Standard ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ultrasoundDevice
Placement of IV line using standard ultrasound.
Ultra-portable ultrasoundDevice
Placement of IV line using ultra-portable ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Standard ultrasound | Other | Comparator Receives: Device: Standard ultrasound |
| Ultra-portable ultrasound | Experimental | Not described Receives: Device: Ultra-portable ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravenous (IV) line placement time
Time in minutes between tourniquet placement and dressing application after placement.
Measured: Day 0
Secondary outcomes (9)
Placement of the IV line successfully obtained from the first puncture
Percentage of cases where the placement of the IV line was obtained from the first puncture
Measured: 12 months (estimated)
Number of skin perforations
Number of skin perforations required to establish the IV line
Measured: Day 0
Overall success rate after 3 punctures
Overall success rate after 3 punctures
Measured: Day 0
Use an alternative solution (central catheter)
Need to use an alternative solution (central catheter)
Measured: Day 0
Patient satisfaction with IV line placement
Patient satisfaction with intravenous line placement (assessed by Likert scale)
Measured: Day 0
Nurse satisfaction with IV line placement
Nurse satisfaction with intravenous line placement (assessed by Likert scale)
Measured: Day 0
Immediate complications related to intravenous access
Number of immediate complications related to intravenous access, including arterial puncture and/or hematoma formation
Measured: Day 0
Delayed complications related to intravenous access
Number of delayed complications related to intravenous access, including extravasation and/or the occurrence of infectious thrombophlebitis
Measured: Day 7
Date of IV line placement and removal
Delays between IV line placement and removal
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start27 Aug 2024
- Primary completionApr 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IV Line Placement With UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296264
- Sponsor's protocol ID
- ULTRACATHLON
- Status last verified
- Oct 2024
- First submitted
- 22 Feb 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-portable Ultrasound vs. Standard Ultrasound to Help Place a Peripheral Catheter in Patients at Risk of Difficult Puncture
- ClinicalTrials.gov ID
- NCT06296264
- Acronym / sponsor ID
- ULTRACATHLON
- Conditions
- IV Line Placement With Ultrasound
- Keywords
- IV line, Ultra-portable ultrasound, Standard ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The placement of an intravenous (IV) line is a common procedure when treating adult patients in critical care, in the emergency room or in the operating room. This simple and minimally invasive procedure can sometimes be made difficult depending on the patient's morphology or their clinical condition. The procedure then becomes time-consuming, anxiety-provoking, painful and its success is uncertain.
The placement of intravenous (IV) lines under ultrasound by nurses is a rapidly developing alternative in intensive care, emergencies and the operating room.
Detailed description
The main objective is to test the hypothesis that intravenous puncture guided by an ultraportable ultrasound machine is faster than puncture guided by a conventional ultrasound machine.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard ultrasound | Other | Device: Standard ultrasoundComparator |
| Ultra-portable ultrasound | Experimental | Device: Ultra-portable ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged at least 18 years old
- Patient with an A-DIVA (Adult Difficult Intravenous Access) score > 1
- Supported by a nurse trained in all the techniques used in the protocol
- Patient having given free, informed and oral consent -
Key exclusion criteria (5 listed)
- Patient who has already been included in the study
- Patient whose inclusion in the study would lead to a delay in treatment
- Adult patient protected by law
- Pregnant woman
- Patient not benefiting from French Social Security system -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard ultrasoundPlacement of IV line using standard ultrasound. | Device | Standard ultrasound |
| Ultra-portable ultrasoundPlacement of IV line using ultra-portable ultrasound. | Device | Ultra-portable ultrasound |
Primary outcome
Intravenous (IV) line placement time
Time frame: Day 0
Time in minutes between tourniquet placement and dressing application after placement.
9 secondary outcomes
Placement of the IV line successfully obtained from the first puncture
Time frame: 12 months (estimated)
Number of skin perforations
Time frame: Day 0
Overall success rate after 3 punctures
Time frame: Day 0
Use an alternative solution (central catheter)
Time frame: Day 0
Patient satisfaction with IV line placement
Time frame: Day 0
Nurse satisfaction with IV line placement
Time frame: Day 0
Immediate complications related to intravenous access
Time frame: Day 0
Delayed complications related to intravenous access
Time frame: Day 7
Date of IV line placement and removal
Time frame: Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard ultrasound and Ultra-portable ultrasound in people with IV Line Placement With Ultrasound, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravenous (IV) line placement time (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.